Clearance Summary
DENTAL COTTON ROLLS received FDA 510(k) clearance under submission number K841327, sponsored by Intl. Verbandstoff-Fabrik Schaffhau. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1984-07-03.
- Submission: K841327
- Applicant / Sponsor: Intl. Verbandstoff-Fabrik Schaffhau
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6050
- Decision date: 1984-07-03
Classification & Regulation
This clearance is catalogued under FDA product code EFN and 21 CFR 872.6050, within the Dental review panel as a Class I device.